Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00820859
Other study ID # IA0144
Secondary ID 5R01AG010172-11
Status Recruiting
Phase N/A
First received January 8, 2009
Last updated July 1, 2009
Start date June 2006
Est. completion date June 2011

Study information

Verified date July 2009
Source National Institute on Aging (NIA)
Contact Jiska Cohen-Mansfield, PhD
Phone 301-770-8453
Email cohen-mansfield@hebrew-home.org
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.


Description:

Clinicians often refer to elderly persons under their care as "agitated." However, agitation is not a diagnosis, but rather, a descriptive term pertaining to a group of behavioral signs and symptoms, defined as socially inappropriate verbal, vocal, or motor (physical) activity that is not judged by an outside observer to result directly from the needs or confusion of the agitated individual. While the literature reports positive effects of non-pharmacological interventions, most studies tend to be based on small samples and do not yield statistically significant results. This study examines the impact of non-pharmacologic interventions tailored through an algorithm labeled TREA (Treatment Routes for Exploring Agitation) using a large, well-controlled, systematic research design.

TREA is an objective, systematic method for developing individualized non-pharmacological treatment plans based on an analysis of the agitated person's unmet needs, past and current preferences, past role-identity, cognitive, mobility, and sensory abilities/limitations, and possible causes for particular agitated behaviors. The methodology calls for ascertaining the type of agitated behavior and the most likely etiology, and then matching the intervention to the etiology and to the participant's characteristics.

The protocol involves the following steps:

- Baseline assessment - using standardized assessments (e.g., MMSE, ABMI, CMAI, Self-identity in dementia), collecting background demographic and medical information as well as systematic observations of the agitated resident

- Intervention exploration - after analyzing potential unmet needs as well as preferences, abilities and identities of each participant, investigators develop a list of potentially successful interventions, examining the effectiveness of a wide range of interventions, from family videos to manipulatives (e.g., puzzles, a tool kit)

- Intervention (treatment) phase — Interventions are systematically provided during the hours of highest agitation (determined at baseline) and observations are conducted at the same time. The treatment phase lasts for 10 days. The placebo control group includes a presentation to staff members as to how to intervene with behavior problems and similar observations of residents.

- Follow-up phase includes repeated assessments without interventions.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Age 60 or older

- Diagnosis of dementia derived from the resident's medical chart at the facility or from an attending physician, as based on DSM-IV criteria and the Report of the NINCDS-ADRDA

- Resident of the facility for at least three weeks so that nursing staff members know the resident well enough to accurately assess him or her

- Identified by nursing staff to exhibit either verbal agitation or physical non-aggressive agitation at least several times a day

Exclusion Criteria:

- Lifelong diagnosis of schizophrenia

- Bipolar disorder diagnosed prior to onset of dementia

- Diagnosis of premorbid mental retardation

- Judged by direct-care nursing staff to have a life expectancy of less than 3 months

- Expected to leave the nursing home (either to enter the hospital or to go home) within the next 4 months

- Agitation manifested less than 6 times a day

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
TREA (Treatment Routes for Exploring Agitation)
Individualized non-pharmacological treatment plan for agitation
Placebo Control Group
A presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group

Locations

Country Name City State
United States Research Institute on Aging Rockville Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cohen-Mansfield J, Libin A, Marx MS. Nonpharmacological treatment of agitation: a controlled trial of systematic individualized intervention. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):908-16. — View Citation

Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. — View Citation

Cohen-Mansfield J. Agitated behavior in persons with dementia: the relationship between type of behavior, its frequency, and its disruptiveness. J Psychiatr Res. 2008 Nov;43(1):64-9. doi: 10.1016/j.jpsychires.2008.02.003. Epub 2008 Apr 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Agitation Behavior Mapping Instrument (ABMI) 10 days of intervention vs. 10 days of baseline No
Secondary affect/mood measured by Lawton's behavior stream assessment 10 days of intervention vs. 10 days of baseline No
See also
  Status Clinical Trial Phase
Completed NCT05686486 - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes N/A
Terminated NCT05451693 - Outreach-ER: A Dementia Care Intervention Program
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Enrolling by invitation NCT06040294 - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills N/A
Completed NCT05114187 - An Internet-Based Education Program for Care Partners of People Living With Dementia N/A
Recruiting NCT06322121 - Vascular Aspects in Dementia: Part 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Recruiting NCT03462485 - Pilot Study of the Effects of Playing Golf on People With Dementia N/A
Active, not recruiting NCT03677284 - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia N/A
Completed NCT03849937 - Changing Talk Online (CHATO) Study N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Completed NCT04571697 - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Recruiting NCT06033066 - Financial Incentives and Recruitment to the APT Webstudy N/A
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT05684783 - Dementia Champions in Homecare
Completed NCT03147222 - Function Focused Care: Fracture Care at Home N/A

External Links